Study for the assessment of clinical non-inferiority and tolerability of different conjugated estrogen vaginal cream ESTROGENON (Sanval Comercio e Industria Ltda) versus PREMARIN (Wyeth Industria Farmaceutica Ltda) in women post menopause.
Phase 3
- Conditions
- Study with the purpose of check clinical non-inferiority and tolerance of two vaginal cream based on the conjugated estrogen manufactured by different manufacturers.Women in post menopause with indications for estrogen replacement therapy.Reproductive Health and Childbirth - Menstruation and menopause
- Registration Number
- ACTRN12610000103066
- Lead Sponsor
- Sanval Comercio e Industria Ltda.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- Female
- Target Recruitment
- 66
Inclusion Criteria
Women in post menopause with indications for estrogen replacement therapy
Exclusion Criteria
Patients with contraindications for estrogen use
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Endometrium thickness - test used: transvaginal ultrasound exam[90 days following randomization]
- Secondary Outcome Measures
Name Time Method Alterations in clinical examination (gynecological) - Citology[90 days following randomization]